Nasal inspiratory resistance trainer

ABSTRACT

Herein we describe a nasal inspiratory resistance trainer (“NIRT”) that increases the difficulty of nasal breathing. The device is specially designed to limit the cross-sectional area of the nostril, which decreases the volume of air a person can easily intake per unit time, typically achieved by reducing tidal volume per breath, reducing respiratory rate, or a combination thereof. Specific implementations are described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of co-pending U.S.patent application Ser. No. 12/371,154, filed on Feb. 13, 2009, whichclaimed the benefit of and priority to U.S. Provisional PatentApplication Ser. No. 61/028,953, filed Feb. 15, 2008, and furtherclaimed the benefit of and priority to U.S. Provisional PatentApplication Ser. No. 61/040,169, filed Mar. 28, 2008, all of which areherein incorporated by reference. This patent application also claimsthe benefit of and priority to U.S. Provisional Patent Application Ser.No. 61/613,533, filed Mar. 21, 2012, and further claims the benefit ofand priority to U.S. Provisional Patent Application Ser. No. 61/666,190,filed Jun. 29, 2012, all of which are herein incorporated by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

Not applicable.

FIELD OF INVENTION

The present invention relates to devices useful in promoting slower,breathing, with reduced volume of air intake per unit time, by limitingnasal respiration. The present invention relates to methods useful forthe treatment, prevention, and/or management of many medical conditions,including asthma, allergy, respiratory disorders, high blood pressure,panic disorder, and other complications that can be negatively impactedby overbreathing.

BACKGROUND OF THE INVENTION

Over the years, a variety of nasal dilators, nose braces, nasal strips,bandages, breathing equipment, jaw retainers, orthodontic inserts,tongue retainers, mechanisms, instruments and other devices have beensuggested to improve breathing quality and have met with varying degreesof success. Devices that require insertion into the nostrils have beentried, with the intent of opening the nostrils and allow more air toenter the nose. Various nasal strips have also been suggested. In oneversion of the Breathe Right® nasal strip manufactured by CNS, Inc. ofMinneapolis, Minn., adhesive strips are lined with two parallel plasticrods. When placed across the bridge of the nose, an adhesive nasal stripadheres to the soft area above the flare of each nostril and provides anexcessive pulling force to lift and open the nasal passages. In anotherversion of the Breathe Right® nasal strip, a flexible metal strip isattached to an adhesive band that is placed on the inside of the nose.The spring action of the metal strip pulls the sides of the noseoutward. Many other devices have been proposed with the intent ofincreasing air flow through the nose.

Another approach, analogous to resistance weight training, orhigh-altitude training, is to practice breathing through artificiallyhigh resistance, thereby potentially increasing the strength of variousmuscles involved in breathing. In other words, rather than makingbreathing easier by increasing air flow through the nose, this approachmakes breathing more difficult during training sessions, hopefullymaking breathing easier during normal conditions. There are numerousinspiratory resistance trainers that are currently marketed, but thesedevices require oral inhalation by users. Such devices may indeedincrease the strength of various muscles involved in breathing, asadvertised, but oral inhalation is generally disfavored by the medicalcommunity, and these devices may train users to revert to oral breathingwhen breathing is difficult, which can be deleterious for users.

Nasal breathing, particularly nasal inhalation, is widely believed to bepreferred to oral breathing, particularly for asthmatics, as nasalinhalation humidifies, warms, and filters incoming air. Bishop et al.(Physiotherapy 93 (2007) 129-136) have recently demonstrated that forcednasal breathing, via mouth taping, has the effect of increasingend-tidal carbon dioxide levels.

Scientific evidence has shown that paced breathing can lower bloodpressure significantly by relaxing the muscles surrounding constrictedblood vessels. The problem for many people, however, is that properpaced breathing does not come naturally or easily. A tonal-basedbiofeedback system has been incorporated into a portable electronicdevice (RESPeRATE®, produced by InterCure, Inc.) to lower blood pressurenaturally by using biofeedback tones to direct breathing and reducebreathing rate. This FDA-approved device has been clinicallydemonstrated to reduce blood pressure. However, it is expensive andrequires the user to wear a chest strap that monitors breathing.

Numerous medical conditions, including asthma, allergy, respiratorydisorders, high blood pressure, panic disorder, and other complications,can be negatively impacted by overbreathing, which can be defined asbreathing a greater volume of air per unit time than is desirable forthe individual. Average adults at rest typically breathe about 10-15times per minute, with an average tidal volume of about 500 mL,corresponding to a typical tidal volume of about 6 L/minute. Forexample, an adult at rest breathing a tidal volume exceeding 15 L/minuteis likely overbreathing. People who chronically overbreathe have chronichyperventilation syndrome. Herein we describe methods and devicessuitable to help treat or prevent these problems.

BRIEF SUMMARY OF THE INVENTION

Herein, a nasal inspiratory resistance trainer (“NIRT”) is describedthat increases the difficulty of nasal breathing. The device isspecially designed to limit the cross-sectional area of the nostril,which decreases the volume of air a person can easily intake per unittime, typically achieved by reducing tidal volume per breath, reducingrespiratory rate, or a combination thereof. The associated methodcomprises uses for the device. A subject utilizing the devices andmethods of the invention may experience the following results: increasedtolerance for carbon dioxide in the body, reduced respiration rate,reduced breathing volume, enhanced nasal to oral breathing ratio,strengthened breathing muscles, and reduced blood pressure.

NIRT devices of the present invention include devices useful forrestricting air flow through the nose. In some embodiments of theinvention, the devices can restrict air flow into the nose with minimalphysical contact with the nose. The device of the present inventionattaches to the exterior surface of the nose and exerts a compressivepressure that pushes the nostrils towards a closed position, therebydecreasing the cross-sectional area through which inhaled air andexhaled air can travel. In some embodiments the device of the presentinvention compresses a portion of the nostril. In some embodiments, thedevice of the present invention compresses over the length of thenostril. In some embodiments, multiple zones of compression with varyingforces are incorporated.

Unlike prior art nose clips useful for swimming and diving, NIRT devicesof the present invention are not intended to prevent nasal breathing.The prior art nose clips pinch the nostrils with excessive compressiveforce, causing the wearer to resort to oral breathing. The NIRT deviceexerts far less force on the nostril, merely decreasing thecross-sectional area of the nostril. It has been shown that the forcenecessary to compress the nostril is 235+/−127 mN. (see Fuller et al.,(1995), Measurement of the EMG-Force Relationship in a Human UpperAirway Muscle, 79 Journal of Applied Physiology, pp. 270-78). Thecompression force exerted by the NIRT device of the present inventioncan be set to utilize a force less than this maximum of 362 mN, or 108mN, irrespective of the distance between the contact points on thenostrils. The NIRT devices encourage the practice (by systematictraining) of nasal breathing in spite of resistance. In all embodimentsof the present invention, the compressive force of the NIRT device isgenerated by rotating a screw which causes compression of the nostril.

In one embodiment, the NIRT comprises two strips connected by a screwmechanism. The NIRT device fits over the bulbous tip of the nose and thestrips contact the lateral portion of the nostril. Accordingly, undernormal use conditions, the human subject rotates the screw mechanismcausing the two strips to move toward each other, thereby compressingthe nostril. The human subject continues to rotate the screw until thecross-sectional area of the nostril is decreased. In another similarembodiment, the NIRT comprises two strips connected by a turnbuckle.

In another embodiment, the NIRT device comprises two screws withsymmetric tips connected by a bridge. The NIRT device fits over thebulbous tip of the nose and symmetric tips contact the lateral portionof the nostril. Accordingly, under normal use conditions, the humansubject rotates the screws causing the two tips to move away from thebridge, thereby compressing the nostril. The human subject continues torotate the screw until the cross-sectional area of the nostril isdecreased. In another similar embodiment, the NIRT comprisesnon-symmetric tips.

An asthmatic subject utilizing a NIRT device according to the methods ofthe invention is exposed to conditions of impaired air flow somewhatanalogous to asthma attacks, and therefore can hone techniques useful indealing with real asthma attacks, including: avoiding panic, reducingrespiratory volume, and breathing through the nose in spite of increasedair resistance. Furthermore, the methods of the invention help toprevent asthma attacks by decreasing habitual hyperventilation andincreasing the proportion of inhalations through the nose relative toinhalations through the mouth.

The present invention is useful for the treatment, management, andprevention of symptoms relating to asthma and rhinitis. For example, themethods and devices of the present invention can be used on subjectswith allergies to allergens such as ragweed or tree pollen, ideallytraining subjects to avoid hyperventilating when airflow is impaired byallergy-induced congestion.

The present invention is also useful for reducing blood pressure.Individuals using a NIRT device of the present invention typicallybreathe more slowly when using the device than they do when not wearingthe device. In most cases, this reduced breathing rate is not the resultof a conscious decision to breathe more slowly, but instead is a naturalresult of the increased inhalation and exhalation times required toprocess a normal volume of air. The NIRT-induced reduction in breathingrate can induce a relaxation of constricted blood vessels, prompting areduction in blood pressure.

The present invention is also useful for treating panic disorder. Aftertraining with the NIRT device, an individual afflicted with panicdisorder can have improved responses to panic attacks, or to conditionsthat may lead to panic attacks, thereby potentially reducing the numberand severity of panic attacks, and reducing the associated symptoms ofpanic disorder.

The present invention is also useful for treating hyperventilationsyndrome, also referred to as chronic hyperventilation syndrome, whichcan cause or exacerbate medical conditions including but not limited toasthma, allergies, and high blood pressure, and which is estimated toafflict between 1% and 10% of the population.

BRIEF DESCRIPTION OF THE DRAWINGS

The summary above, and the following detailed description, will bebetter understood in view of the drawings which depict details ofpreferred embodiments.

FIG. 1 shows a schematic cross-sectional view of one embodiment of aNIRT device with a bridge.

FIG. 2 shows a side view of the device shown in FIG. 1.

FIG. 3 shows a schematic cross sectional view of a NIRT device with sidewalls.

FIG. 4 shows a side view of the device shown in FIG. 3.

FIG. 5 shows a schematic cross sectional view of a NIRT device with aturnbuckle.

FIG. 6 shows a schematic cross sectional view of another embodiment of aNIRT device utilizing multiple screws and symmetric tips.

FIG. 7 shows a top view of the device shown in FIG. 6.

FIG. 8 shows a schematic cross sectional view of a NIRT device utilizingmultiple screws and non-symmetric tips.

FIG. 9 shows a top view of the device shown in FIG. 8.

FIG. 10 shows a schematic view of a screw.

FIG. 11 shows a prior art nose clip in a deflected position.

FIG. 12 shows a side view of the devices in FIG. 1 in a deflectedposition.

FIG. 13 shows a side view of the devices in FIG. 1 in a deflectedposition, which exerts the same force as the device in FIG. 12.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is directed to a nasal inspiratory resistancetrainer (“NIRT”). The present invention is also directed to usefulmethods for the treatment, prevention, and/or management of respiratorydisorders and associated complications.

A nasal inspiratory resistance trainer (NIRT) 10 in accordance with thepresent invention is illustrated generally in FIG. 1. The NIRT devicehas a first strip 1 and a second strip 2. The first strip 1 and thesecond strip 2 are oriented substantially parallel to each other. Asshown, the first strip 1 and the second strip 2 are generallyrectangular. As shown in FIG. 1, the first strip 1 and the second strip2 have a consistent longitudinal width. Other shapes are contemplatedsuch as spoon-shaped, teardrop or oval.

The first strip 1 contains a threaded hole capable of accepting a screw3. This unitary structure may be easier to manufacture. Alternatively,the first strip 1 contains a non-threaded hole. A nut is aligned withthe non-threaded hole and attached to the first strip 1. The screw 3would pass through both the nut and the non-threaded hole. The materialof first strip 1 and the second strip 2 is selected to maximize comfortfor the human subject while minimizing skin irritations. The first strip1 and the second strip 2 are formed of a biocompatible material.Suitable materials for first strip 1 and the second strip 2 include butare not limited to plastics and metals. Suitable materials combine thestrength and rigidity required, at a relatively inexpensive cost.

Screw 3 is a commercially-available screw in a standard size. Suitablematerials for screw 3 include but are not limited to plastics (e.g.,nylon) and metals. Suitable materials combine the light-weightinessrequired, at a relatively inexpensive cost. To aid in the operation ofthe device, screw 3 may be striped as shown in FIG. 10. This is a visualcue to the human subject as to how far to rotate the screw.

Spring 7 encircles screw 3. Spring 7 presses against the first strip 1and second strip 2 in the uncompressed state. As the screw is rotated,spring 7 compresses. The spring 7 facilitates the smooth traverse of thefirst strip 1 toward the second strip 2. The spring 7 also prevents thesecond strip 2 from sliding toward the first strip 1.

The NIRT device may comprise a means for preventing rotation. As shownin FIGS. 1-2, bridge 4 constrains the first strip 1 to the second strip2. Bridge 4 prevents the first strip 1 from rotating when the screw 3 isrotated. With the bridge 4, when screw 3 is rotated, the first strip 1traverses the gap between the first strip 1 and the second strip 2,rather than rotating in place. Alternatively, as shown in FIGS. 3-4,sidewalls 5 constrain the first strip 1 to the second strip 2. Thesidewalls are attached to the second strip 2. The sidewalls 5 are notattached to the first strip 1; rather, the first strip 1 slides alongthe sidewalls 5. When screw 3 is rotated, the first strip 1 traversesthe gap between the first strip 1 and the second strip 2, rather thanrotating in place. While the second strip 2 and the sidewalls 5 areshown as separate components, an integral structure could be formed.

As shown in FIGS. 1-4, the head of the screw 3 is located near secondstrip 2. However, due to the symmetry of the design, the head of thescrew 3 could be located near first strip 1. To aid in rotation, a knob(not shown) is affixed to screw. Suitable materials include rubber,plastic, metal, nylon, or ceramics. The knob allows for the screw 3 tobe easily turned. In order to aid in turning, a washer (not shown) maybe inserted between the knob and the second strip 2. Suitable materialsfor the washer include metal, plastic or nylon.

The use of screw 3 allows the device to have a greater degree ofprecision. Small increments of force can be adjusted with the slightturn of screw 3. The device 10 can be adjusted to fit a wide variety ofnoses, since the gap between the first strip 1 and the second strip 2can be increased or decreased in an infinite number of incrementalsteps.

In operation, the devices shown in FIGS. 1-4 function similarly. TheNIRT device 10 is placed over the bulbous tip of the nose of a humansubject. The first strip 1 contacts one nostril and the second strip 2contacts the other nostril. Accordingly, under normal use conditions,the human subject rotates the screw 3 causing the first strip 1 to movetoward the second strip 2, thereby compressing the nostrils. The humansubject continues to rotate the screw until the cross-sectional areas ofthe nostrils are decreased.

In another embodiment shown in FIG. 5, the NIRT device has a first strip1 substantially similar to the first strip 1 in FIGS. 1-4. The firststrip 1 contains a threaded hole capable of accepting a turnbuckle 6.This unitary structure may be easier to manufacture. Alternatively, thefirst strip 1 contains a non-threaded hole. A nut is aligned with thenon-threaded hole and attached to the first strip 1. The turnbucklewould pass through both the nut and the non-threaded hole. The NIRTdevice has another strip 1′. The strip 1′ contains a threaded holecapable of accepting a turnbuckle 6. Alternatively, the strip 1′contains a non-threaded hole. A nut is aligned with the non-threadedhole and attached to the strip 1′. The turnbuckle would pass throughboth the nut and the non-threaded hole.

In order for the device to function, the threaded hole on strip 1′ musthave the opposite threading from the threaded hole on strip 1. Forinstance, if the threaded hole on the first strip 1 has right handedthreads, then the threaded hole on strip 1′ must have left handedthreads. Alternatively, if nuts are utilized, the nut attached to strip1 must have opposite threading as the nut attached to strip 1′

The first strip 1 and strip 1′ are formed of a biocompatible material.Suitable materials for first strip 1 and strip 1′ include but are notlimited to plastics and metals. Suitable materials combine the strengthand rigidity required, at a relatively inexpensive cost.

Turnbuckle 6 is a commercially-available turnbuckle in a standard size.Suitable materials for turnbuckle include but are not limited toplastics and metals. Suitable materials provide the requisite lowweightat a relatively inexpensive cost. To aid in the operation of thedevice, the turnbuckle may be striped (not shown), similar to the screwshown in FIG. 10. This is a visual cue to the human subject as to howfar to rotate the turnbuckle.

As turnbuckle 6 is rotated, the first strip 1 and the strip 1′ movetoward each other. To aid in rotation, a knob (not shown) could beaffixed to the middle of the turnbuckle 6. Suitable materials includerubber, plastic, metal, or ceramics. The knob allows for the turnbuckle6 to be easily turned.

The NIRT device may comprise a means for preventing rotation. Bridge 4(not shown) constrains the first strip 1 to strip 1′. Bridge 4 preventsthe first strip 1 and strip 1′ from rotating when the turnbuckle 6 isrotated. With the bridge, when turnbuckle 6 is rotated, the first strip1 and strip 1′ move toward each other, rather than rotating in place.Alternatively, sidewalls 5 (not shown) constrain the first strip 1 tostrip 1′. The sidewalls are attached to strip 1′. The sidewalls 5 arenot attached to the first strip 1. Rather the first strip 1 slides alongthe sidewalls 5. When turnbuckle 6 is rotated, the first strip 1 andstrip 1′ move toward each other, rather than rotating in place

In operation, the devices shown in FIGS. 1-5 function similarly. TheNIRT device 10 is placed over the bulbous tip of the nose of a humansubject. The first strip 1 contacts one nostril and the strip 1′contacts the other nostril. Accordingly, under normal use conditions,the human subject rotates the turnbuckle 6 causing the first strip 1 andthe strip 1′ to move toward each other, thereby compressing thenostrils. The human subject continues to rotate the turnbuckle until thecross-sectional areas of the nostrils are decreased.

The devices in FIGS. 1-5 have a unique feature not found in prior artdevices. Prior art nose clips have a single neutral position. Theneutral position is defined as the position where stresses or strains onthe device are lowest. With a single neutral position, prior art devicesreturn to one pre-determined distance. FIG. 11 demonstrates thisconcept. FIG. 11 shows as typical, prior art nose clip 20. The prior artnose clip 20 has a single neutral position where the prior art nose clip20 has zero deflection. In the neutral position, the legs of the priorart nose clip 20 are a distance 21 apart. The distance 21 is based onthe manufactured shape of the prior art nose clip 21. When stretched toa distance beyond 21 as shown in FIG. 11, the prior art nose clip 20applies a force directly proportional to the deflection, according tothe formula:

P=3 δ_(max) EI/L ³

where δ_(max) is the maximum deflection, E is the modulus of elasticity,I is the moment of inertia, and L is the length of the beam.

As such, prior art nose clip 20 has to deflect a greater distance forlarger noses and therefore applies a greater force. For any distance theprior art device is spread apart, the force is a known value and can notbe altered. In other words, the device is not capable of applying a setforce, such as 375 mN, to noses of different shapes. Typically, theprior art nose clips cannot apply a specified force over a range ofdifferent force values because they are intended to prevent nasalbreathing. Prior art nose clips apply excess force in order tocompletely block the flow of air through the nose. The design of priorart nose clips is a product of this intended use.

The devices shown in FIGS. 1-5 function in a completely differentmanner. A NIRT device has an infinite number of neutral positions. Theneutral position is defined as the position where stresses or strains onthe device are lowest. A neutral position is determined based onrotation of the screw 3 or turnbuckle 6 which shortens or lengthens thedistance between the first strip 1 and either the second strip 2 orstrip 1′. In other words, a NIRT device has an infinite number neutralposition where first strip 1 and either the second strip 2 or strip 1′both have zero deflection. In the neutral position, the distance betweenfirst strip 1 and either the second strip 2 or strip 1′ is notdetermined by the manufactured shape of the device like distance 21shown in FIG. 11.

As shown in FIG. 12, the screw 3 of the NIRT device has been rotated sothat strip 1 and second strip 2 are separated by a distance 11. In thisneutral position, the first strip 1 and second strip 2 have zerodeflection. When stretched to a distance beyond 11 as shown in FIG. 12,the NIRT devices applies a force directly proportional to thedeflection, according to the formula:

P=3 δ_(max) EI/L ³

where δ_(max) is the maximum deflection, E is the modulus of elasticity,I is the moment of inertia, and L is the length of the beam.

However, as shown in FIG. 13, the screw of the NIRT device has beenrotated so that strip 1 and strip 2 are separated by a distance 110. Inthis neutral position, the first strip 1 and second strip 2 have zerodeflection. When stretched to a distance beyond 110 shown in FIG. 12,the NIRT devices applies a force directly proportional to thedeflection. If the deflection is the same for FIG. 12 and FIG. 13, thenthe force applied by the NIRT device is the same. In other words, thedevice is capable of applying a set force regardless of the distanceseparating the first strip and the second strip. As such, the device iscapable of applying a force, such as 375 mN, to noses of differentshapes. The purpose of the NIRT devices is to reduce the cross-sectionalarea of the nostril. The design of the device is critical to achievingthis intended use.

A NIRT device 10 in accordance with the present invention is illustratedgenerally in FIG. 6. In the embodiment shown, the NIRT device has twoscrews 3 and two nuts 8. Alternatively, nuts 8 could be replaced with asolid block of material with a threaded hole. In one embodiment, thescrews 3 are oriented substantially parallel to each other. The nuts 8are attached to a bridge 4. Alternatively, nuts 8 and bridge 4 could bea unitary structure. Bridge 4 is a means for preventing rotation.

As shown in FIG. 6, screws 3 are attached to tips 9. In one embodiment,tip 9 rotates when screw 3 rotates. This structure is easier tomanufacture. In another embodiment, tip 9 does not rotate when screw 3rotates. This structure may be more comfortable for the human subject100, since the tip will not rub against the nose during rotation. Tip 9can be attached to the screw through any means typical in the art. Asshown in FIG. 7, each tip 9 is symmetrical with respect to the axis ofscrew 3. In other words, each tip 9 has a consistent width with respectto the axis of screw 3. To aid in the operation of the device, thescrews 3 may be striped as shown in FIG. 10. This is a visual cue to thehuman subject as to how far to rotate the screw.

The NIRT device 10 is placed over the bulbous tip of the nose of a humansubject. The first tip 9 contacts one nostril and the second tip 9contacts the other nostril. Accordingly, under normal use conditions,the human subject then rotates each screw 3 causing the tip 9 to moveaway from the bridge 4, thereby compressing the nostril. The humansubject continues to rotate the screw until the cross-sectional area ofthe nostril is decreased. The human subject rotates the other screw 3 ina similar manner causing the other tip 9 to move away from the bridge 4.

Alternatively, screws 3 are attached to tips 9′. Each tip 9′ rotateswhen the attached screw 3 rotates. Unlike the tips 9 shown in FIG. 6,the tips 9′ are not symmetric with respect to the axis of screw 3. Asshown in FIG. 8, each tip 9′ has an extension that slants away from thescrew 3. To aid in the operation of the device, the screws 3 may bestriped as shown in FIG. 10. This is a visual cue to the human subjectas to how far to rotate the screw.

In operation, the human subject rotates the screws 3 to a desiredlength. At this point in time, the device is positioned similar to thepositioning shown in FIG. 9. In other words, each tip has an extensionthat is positioned to slant away from the screw 3. Then, the NIRT device10 is placed over the bulbous tip of the nose of a human subject and thetips 9′ rest against the nostril. The human subject grasps both screws 3and rotates the screws. When the screws 3 are rotated between 90 and 180degrees, the cross-sectional area of the nostril is decreased.

The NIRT device is far more comfortable to wear than prior art noseclips because the NIRT applies a smaller compressive force. The NIRTdevice aims at reducing the cross-sectional area of the nostrils ratherthan closing them completely. As such, the design of the NIRT device isa product of this intended use. In some embodiments, the extent ofavailable cross-sectional area in the nasal passage through which aircan flow is controlled by moderating the compressive pressure of thedevice. In some embodiments, said cross-sectional area is controlled bythe placement of the device.

The present invention is useful for the treatment, management, andprevention of symptoms relating to respiratory disorders such as asthmaand rhinitis. The methods of the present invention are useful for thetreatment of both allergic asthma and non-atopic asthma, and are usefulfor the treatment of allergic rhinitis and non-allergic rhinitis. Forexample, the methods and devices of the present invention are useful intraining a child suffering from seasonal allergic rhinitis (e.g., “hayfever”) to avoid overbreathing and to better cope with nasal congestion.There is a tendency in many individuals with asthma or rhinitis toinhale more air than is needed, which can decrease carbon dioxide levelsin the blood, which can lead to increased mucus production, therebyexacerbating congestion and often increasing the tendency tohyperventilate. The methods and devices of the present invention assistin disrupting this cycle.

There has been considerable interest in the Buteyko breathing technique,which was developed in Russia by Konstantin Buteyko. The ButeykoBreathing Centre claims over 90% of asthmatics who completed the Buteykocourse in Russia no longer need medication. Further, these results havebeen replicated in Australia. Butevko Trials and Results, ButeykoBreathing Centre, http://www.buteyko.co.uk/buteyko-trials.htm. TheButeyko technique is based on the hypothesis that asthma is caused byhyperventilation. The technique teaches the ability to reduce thefrequency and depth of breathing. In a recent randomized control trial,asthmatics were taught the Buteyko technique. Cooper et al., Effect ofTwo Breathing Exercises (Buteyko and Pranayama) in Asthma: A RandomizedTrial, 58 Thorax 674-79 (2006). Training was given in small groups tolearn the exercises. Participants were asked to use the technique twicedaily. Additionally, participants were asked to use the technique torelieve asthma symptoms and only to use their bronchodilator if thatfailed. The results show that the Buteyko technique reduced asthmasymptoms and bronchodilator use compared with other groups who did notuse the technique.

However, during an attack, an asthmatic's breathing is closer tohyperventilation, where the body is in a state of faster and deeperbreathing. The device of the present invention assists asthmatics inreducing the frequency and depth of breathing by training with a devicethat reducing the cross-sectional area of the nasal passage. The deviceof the present invention is a passive constraint that allows asthmaticsto practice constrained breathing in a non-emergency setting. By honingin on personal tempos and patterns to correct hyperventilation,asthmatics may be able to better handle future attacks. It has also beenshown that asthmatics over-perceive nasal resistance, and switch fromnasal to oral breathing at lower resistive loads. Hallani et al.,Asthmatics Have Increased Sensitivity to Nasal Loads and Tend to BreatheOro-nasally, American Thoracic Society Annual Scientific Meeting. 163Am. J. Respir. Crit. Care Med. A60 (2001). This suggests that anyreduction in compression is preferably incremental to accommodate thediffering sensitivities of asthmatics. The device of the presentinvention achieves this goal by incorporation a screw mechanism. Thescrew in all embodiments allows for incremental adjustments to thecompression of the nostril. Fine-tune adjustments allow asthmatics tohone techniques for nasal breathing under different levels of pressure,without resorting to oral breathing. Additionally, only one NIRT isnecessary for both beginners and advanced users, since the pressure canbe varied from nearly 0 mN to full compression of the nostril atapproximately 362 mN.

Nasal breathing, in general, is preferred to mouth breathing forasthmatics. Mouth breathing allows airborne allergens to reach the lowerairways, and dries the bronchial mucous membrane. One study suggeststhat a mere 60 minutes of forced mouth breathing results in asignificant decrease in lung function as measured by FEV₁. Hallani etal., Enforced Mouth Breathing Decreases Lung Function in MildAsthmatics, 13 Respirology 553 (2008). Additional research has favorednasal breathing. One recent study (Bishop et al., The use of mouthtaping in people with asthma: a pilot study examining the effects onend-tidal carbon dioxide, (2007), 93 Physiotherapy p. 129) demonstratedthat forced nasal breathing, via mouth taping, has the effect ofincreasing end-tidal carbon dioxide levels.

The device of the present invention can be used to promote nasalbreathing. By overcoming the perceived increase in resistance, users,including individuals with allergies or asthma, can train themselves tomaintain nasal breathing in compromising situations. Nasal breathingthrough the duration of an attack forces air through the conditioningprocess of the nasal mucosa and prevents the decrease in lung functionassociated with mouth breathing.

The methods and devices of the present invention may be useful forreducing blood pressure. This outcome is particularly relevant forindividuals having hypertension or prehypertension, and may be mosteffective when used by individuals who typically have high respirationrates. That said, the methods and devices of the invention may also beuseful for individuals not afflicted with hypertension orprehypertension, particularly when used on a preventative basis.Individuals with prehypertension have a systolic pressure (top number)ranging from 120 to 139 millimeters of mercury (mm Hg) or a diastolicpressure (bottom number) ranging from 80 to 89 mm Hg. Individuals withhypertension have a systolic pressure greater than 140 mm Hg or adiastolic pressure greater than 90 mm Hg.

In one embodiment of the invention, subjects having hypertension orprehypertension train with the NIRT device three or more times per week,for at least ten minutes per session. Subjects training with the devicemay experience reduced blood pressure relative to what the bloodpressure would otherwise be in the absence of training with the device.To date, such training has only been performed on individuals havingnormal blood pressure, and clinical trials are planned to investigatethe extent of blood pressure reduction that can be achieved by trainingwith NIRT devices.

The methods and devices of the present invention are compatible withother methods for reducing blood pressure, including exercise, use ofother medical devices to reduce blood pressure, and pharmacotherapy suchas administration of angiotensin-converting enzyme inhibitors,angiotensin II receptor blockers, beta blockers, and calcium channelblockers.

The methods and devices of the present invention may be useful fortreating panic disorder. Recent evidence suggests that rather thantaking deep breaths during a panic attack, a more effective strategyduring or preceding panic attacks may be to reduce breathing volume, forexample by breathing slower and more shallow, thereby boosting carbondioxide levels. Patients trained to breathe slower and shallower showedsignificant improvement in panic disorder symptoms. (Meuret et al.,“Feedback of End-tidal pCO2 as a Therapeutic Approach for PanicDisorder”, Journal of Psychiatric Research, 42 (2008), 560-8).

In one embodiment of the invention, subjects having panic disorder trainwith the NIRT device three or more times per week, for at least tenminutes per session. Subjects training with the device can improve theirability to handle a panic attack, or even to ward off a panic attack bybreathing less and retaining carbon dioxide.

In preferred embodiments of the invention, the amount of use isprescribed based upon the patient's needs. For example, an adolescentpatient suffering from asthma can use the NIRT device multiple times perday for months or years. The duration and frequency of training sessionsusing the NIRT devices of the present invention can vary according tothe methods of the invention. For example, the NIRT can be applieddaily, or can be used sporadically. It can be applied for a short time,or can be utilized for multiple hours. In preferred embodiments, theNIRT is applied to the nose and utilized for at least five minutes atleast one time per week.

Incorporation by Reference

All publications, patents, and patent applications cited herein arehereby expressly incorporated by reference in their entirety and for allpurposes to the same extent as if each was so individually denoted.

Equivalents

While specific embodiments of the subject invention have been discussed,the above specification is illustrative and not restrictive. Manyvariations of the invention will become apparent to those skilled in theart upon review of this specification. The full scope of the inventionshould be determined by reference to the claims, along with their fullscope of equivalents, and the specification, along with such variations.

The articles “a” and “an” are used herein to refer to one or to morethan one (i.e. to at least one) of the grammatical object of thearticle. By way of example, “a spring” means one spring or more than onespring.

Any ranges cited herein are inclusive.

We claim:
 1. A method of limiting nasal respiration in a human subject,comprising: placing a first contact point of a nasal inspiratoryresistance trainer in contact with the external surface of the rightnostril of said human subject; placing a second contact point of saidnasal inspiratory resistance trainer in contact with the externalsurface of the left nostril of said human subject; adjusting a screwmechanism; wherein said nasal inspiratory resistance trainer is capableof exerting a specified amount force regardless of the distance betweensaid first contact point and said second contact point.
 2. The method ofclaim 1, wherein said nasal inspiratory resistance trainer has aninfinite number of neutral positions.
 3. The method of claim 2, whereinsaid neutral position is the position where stresses or strains on thedevice are lowest.
 4. The method of claim 2, wherein the step ofadjusting the screw mechanism comprises adjusting the screw mechanismfrom a neutral position to a position of greater stresses or strains. 5.The method of claim 2, wherein said nasal inspiratory resistance traineris capable of deflecting a specified distance regardless of the size ofthe nose of said human subject.
 6. The method of claim 1, wherein saidnasal inspiratory resistance trainer is capable of exerting a specifiedamount force regardless of the size of the nose of said human subject.7. The method of claim 1, wherein said specified amount force is lessthan 362 mN.
 8. The method of claim 7, wherein said specified amountforce is between 108 mN and 362 mN.
 9. The method of claim 1, whereinsaid specified amount of force partially decreases the cross-sectionalarea of the nostril.
 10. The method of claim 9, wherein thecross-sectional area of the nostril is reduced by 25% to 75%.
 11. Themethod of claim 1, wherein the total volume of air inhaled per unit timeby said human subject using said nasal inspiratory resistance trainer isdecreased relative to the total volume of air inhaled per unit time bysaid human subject when not using said nasal inspiratory resistancetrainer.
 12. The method of claim 1, wherein the method is useful for thetreatment, prevention, and/or management of medical conditions that areexacerbated by overbreathing.
 13. The method of claim 12, wherein saidmedical condition is selected from the group consisting of: high bloodpressure, panic disorder, allergies, and asthma.
 14. The method of claim1, wherein said human subject is asthmatic.
 15. The method of claim 14,wherein said human subject hones one or more techniques useful indealing with real asthma attacks selected from the group consisting ofavoiding panic, reducing respiratory volume, and breathing through thenose in spite of increased air resistance.
 16. The method of claim 14,wherein said human subject decreases habitual hyperventilation andincreases the proportion of inhalations through the nose relative toinhalations through the mouth.
 17. The method of claim 12, wherein saidoverbreathing occurs on a chronic basis, and wherein said human subjecthas chronic hyperventilation syndrome.
 18. The method of claim 1,wherein said nasal inspiratory resistance trainer enhances respirationquality in said human subject.